AGC Biologics services

For customers preparing for commercial approval and post commercial approval, Process Validation is a critical and significant set of activities. AGC Biologics has a well-defined approach with supporting Quality Systems to provide you with a targeted path through late-phase Process Validation. Our systems are based on the FDA’s 2011 Approved Guidance for Industry and ICH guidelines, using a risk-based lifecycle approach and consists of three basic stages with supporting validation activities.

AGC Biologics develops analytical methods for product release, product characterization and process development support.
Robust and validated release methods, including bioassays, are developed to ensure the identity, safety, purity and potency of your product. Our in-house bioassay group specializes in analytical development and validation of cell-based assays. This speeds results and eliminates the need for third party interactions.

At AGC Biologics, the enhancement and continuous improvement of Quality is the responsibility of every individual. As part of our intent focus of our customers’ compliance needs, we track new regulations and monitor and implement new regulatory trends. Our Quality Assurance teams are dedicated to ensuring compliance with all necessary regulations and requirements.